MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068505110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Dizziness (2194); Urinary Frequency (2275); Injury (2348); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Weight Changes (2607); Intraoperative Pain (2662); Dysuria (2684); Constipation (3274); Paresthesia (4421); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The device was implanted at (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6), 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.(b)(6).Block h6: patient codes e1310, e2328, e1309, e0402, e2401, e0123, e2330, e2112, e1405, capture the reportable events of infection, urinary tract, obstruction, ureter/urethra (kidney stones), urinary retention (incomplete bladder emptying), hypersensitivity, injury, nos (not otherwise specified) for genital herpes, gerd (gastroesophageal reflux disease), subacute myoclonic spinal neuronitis, nerve damage (obturator neuralgia, pudendal neuralgia), pain (pelvic pain, groin pain, perineal pain, vaginal pain, joint pain, back pain, hip pain, bladder pain, allodynia), pain, intraoperative (acute), and dyspareunia respectively.Impact codes f1202, f1903, f19, f23, f22, and f2303 capture the reportable events of disability (debilitated), device explantation (removal of the vaginal part of sub-urethral transobturator sling, bilateral groin mesh removal), surgical intervention (osteotomy of left and pubic bone, kelly plication), unexpected medical intervention (pudendal nerve block, urodynamic study), unexpected diagnostic intervention (bladder scan, urine culture, urinalysis, cystoscopy), and medication required (botox injection to pelvic floor muscles) respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a transobturator vaginal sling and cystoscopy procedure performed on (b)(6), 2018.For the treatment of stress urinary incontinence (sui).On (b)(6), 2018, the patient mentioned that she still had residual sui for 7 weeks post sling procedure, with symptoms that included dyspareunia, embarrassed, incontinence of urine, pelvic pain, and sexual dysfunction.Furthermore, the symptoms were exacerbated by coughing, sneezing, laughing, exercise, heavy lifting, and full bladder.In addition, pertinent medical history included recurrent urinary tract infections, kidney stones, rectocele, pelvic pain, stress urinary incontinence, and hematuria.Also, she had undergone bladder scan, and urine culture.On (b)(6), 2019, she presented ongoing sui, frequency, bilateral groin pain, and dyspareunia.Her sui's onset was 10 years ago, and got worsen over time.Also, she had nocturia once to twice onset for about 9 months ago, and urgency only at night.Moreover, she only drank 1 serving of caffeine daily.The patient also experienced burning sensation from time to time, and only had a treatment once for urinary tract infection (uti).She stated that she's not sexually active due to pain which was not the case prior to her sling.Reportedly, there was no improvement on prior myrbetriq trial.She had 2 kidney stones with the last one on (b)(6) 2019, and had genital herpes which was treated with acyclovir, however, she had an outbreak a month ago.During the review of systems, the patient had mentioned that she had weight gain, dizziness, joint pain and back pain.Also, the patient had painful urination, frequent, urgent urination, incontinence, incomplete bladder emptying, nighttime urination, sexual dysfunction, vaginal pain, and vaginal burning.Furthermore, the patient had severe urethral hypermobility, perfused cough stress test with no mesh exposed, and sling at mid-urethra and was tender.Reportedly, there was levator tenderness on the right, and pain at the inner aspect of muscles.On (b)(6), 2019, cystoscopy, urodynamic study (uds), and complete urinalysis was performed to the patient.The patient was experiencing pelvic, perineal, vaginal and groin pain, stress incontinence, and mixed incontinence ever since she had the transobturator sling procedure.The physician had a discussion with the patient about proceeding with sling removal and to continue pelvic floor physical therapy (pfpt).The patient also understood that sui may still persist or worsen, and pain could not be resolved with the treatment.However, she still wanted to proceed with the sling removal and urethropexy.On (b)(6), 2019, the patient presented to pelvic health physical therapy (pt) with primary complaints and limitations with pelvic pain, vaginal pain, and groin pain.The patient was centrally sensitized with b multi-angle movement, severe reactivity upon light palpation through b adductors, severe pain upon palpation of all layers of pelvic floor muscles (pfm), observing moderate amounts of urine leakage with request to cough.On (b)(6), 2021, she developed fecal incontinence, and had bilateral pain but was slightly more on the right, it was sharp and excruciating.She had significant bladder burning.Since the surgery, the patient had not been able to have intercourse which was extremely painful.Moreover, she also developed numbness in both of her buttocks especially when sitting, and that numbness was around her rectum.The patient had fecal incontinence, but also had constipation.She had nocturia twice.Reportedly, she had significant hypersensitivity in the perineal area.The patient felt that she was completely debilitated since implantation of mesh.On (b)(6), 2021, the patient was here for her pre-surgical counselling.She was scheduled to undergo removal of obtryx mesh - both vaginal part and bilateral groin, bilateral pudendal nerve block and botox injection to pelvic floor muscles.She was complaining of severe perineal/vulvar and vaginal pain.She had significant hypersensitivity in the clitoris and labia.Reportedly, the patient stated that she was not able to wear any underwear because for this burning hypersensitivity pain.She also stated that she was experiencing significant urinary incontinence.Furthermore, it was observed that there was bilateral lower back tenderness, and bilateral lower abdominal tenderness very significant bilateral spasm of the pelvic floor muscles especially obturator internist muscles bilaterally significantly sensitivity to touch in the clitoris, bilateral labia in the inner thighs.During assessment, it was noted that the patient had allodynia, spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.During counseling, the physician had mentioned that the patent will most likely need repeat injections of botox to the pelvic floor muscles together with pudendal nerve blocks every three months for many years ahead.On (b)(6), 2021, the patient had undergone vaginal mesh removal, groin mesh removal, pudendal nerve block, botox injection into pelvic floor, kelly plication, and osteotomy of pubic bone procedure.It was then observed that the transobturator sub - urethral sling was densely attached to the medial aspect of the obturator foramen bilaterally, and there was a significant bilateral spasm of pelvic floor muscles.She was then admitted for postoperative medical management status post botox injection to pelvic floor muscles, pudendal nerve block, bilateral groin mesh removal, removal of the vaginal part of sub- urethral transobturator sling, osteotomy of left and pubic bone, and kelly plication for history of complication of implanted vaginal mesh, spastic pelvic floor syndrome, pudendal neuralgia, obturator neuralgia, complex regional pain syndrome type ii.Postoperatively, the patient reported postoperative pain, with pain rated around 5/10, however, earlier it was rated up to 10/10, and she had some left tingling.According to the surgical pathology report, there was a soft tissue, left and right groin, and vagina, foreign mesh material that was attached and embedded to the red - brown and gray- white soft tissue.

Manufacturer Narrative

Correction: b3, b5, h6: patient codes and impact codes.Block b3 date of event: the exact event onset date is unknown; however, it was reported that the patient had recurrent symptom on (b)(6) 2018.Block e1: this event was reported by the patient's legal representation.(b)(6).Block h6: patient codes e1310, e2328, e1309, e0402, e2401, e0123, e2330, e2112, e1405 and e2101 capture the reportable events of infection, urinary tract, obstruction, ureter/urethra (kidney stones), urinary retention (incomplete bladder emptying), hypersensitivity, injury, nos (not otherwise specified) for genital herpes, gerd (gastroesophageal reflux disease), subacute myoclonic spinal neuronitis, nerve damage (obturator neuralgia, pudendal neuralgia), pain (pelvic pain, groin pain, perineal pain, vaginal pain, joint pain, back pain, hip pain, bladder pain, allodynia), pain, intraoperative (acute), dyspareunia and adhesion respectively.Impact codes f1202, f1903, f19, f23, f22, and f2303 capture the reportable events of disability (debilitated), device explantation (removal of the vaginal part of sub-urethral transobturator sling, bilateral groin mesh removal), surgical intervention (osteotomy of left and pubic bone, kelly plication), unexpected medical intervention (pudendal nerve block, urodynamic study), unexpected diagnostic intervention (bladder scan, urine culture, urinalysis, cystoscopy), and medication required (botox injection to pelvic floor muscles) respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a transobturator vaginal sling and cystoscopy procedure performed on (b)(6) 2018.For the treatment of stress urinary incontinence, sui.On (b)(6) 2018, the patient mentioned that she still had residual sui for 7 weeks post sling procedure, with symptoms that included dyspareunia, embarrassed, incontinence of urine, pelvic pain, and sexual dysfunction.Furthermore, the symptoms were exacerbated by coughing, sneezing, laughing, exercise, heavy lifting, and full bladder.In addition, pertinent medical history included recurrent urinary tract infections, kidney stones, rectocele, pelvic pain, stress urinary incontinence, and hematuria.Also, she had undergone bladder scan, and urine culture.Exam revealed good healing, the urethra was quite stable, but there was a fair amount of leakage with cough.The assessment was stress urinary incontinence.The patient was advised that she had tremendous leakage pre-op and the mesh sling has not solved it, so options included a bulking agent followed by an autologous pv sling.The patient was interested but her insurance would not cover coaptite.Urinalysis showed pyuria, and a culture was submitted.Results were not included in the medical records provided.On (b)(6) 2019, the patient presented for a second opinion for mixed incontinence, ongoing sui, frequency, bilateral groin pain, and dyspareunia.Her suis onset was 10 years ago that got worse over time.Also, she had nocturia once to twice onset for about 9 months ago, and urgency only at night.Moreover, she only drank 1 serving of caffeine daily.The patient also experienced burning sensation from time to time, and only had a treatment once for urinary tract infection uti.She stated that she is not sexually active due to pain which was not the case prior to her sling.Reportedly, there was no improvement on prior myrbetriq trial.She had 2 kidney stones with the last one on (b)(6) 2018, and had genital herpes which was treated with acyclovir, however, she had an outbreak a month ago.During the review of systems, the patient had mentioned that she had weight gain, dizziness, joint pain and back pain.Also, the patient had painful urination, frequent, urgent urination, incontinence, incomplete bladder emptying, nighttime urination, sexual dysfunction, vaginal pain, and vaginal burning.Exam revealed severe urethral hypermobility, perfuse cough stress test with no mesh exposed, and sling at mid-urethra and was tender.Reportedly, there was levator tenderness on the right, and pain at the inner aspect of muscles.Treatment options included sling excision and subsequent autologous pv sling, but the patient was advised she would need pelvic floor physical therapy pfpt and urodynamics study uds prior.On (b)(6) 2019, cystoscopy, uds, and complete urinalysis were performed.The patient was experiencing pelvic, perineal, vaginal and groin pain, stress incontinence, and mixed incontinence ever since she had the transobturator sling procedure.No abnormalities were noted on cystoscopy.Uds revealed abdominal leak point pressure allp of 58-128 cm h2o and pseudodyssenergia consistent with dysfunctional voiding.The assessment was pelvic and perineal pain, stress incontinence, and mixed incontinence.The physician had a discussion with the patient about proceeding with sling removal and to continue pelvic floor physical therapy pfpt.The patient also understood that sui may still persist or worsen, and pain could not be resolved with the treatment.However, she still wanted to proceed with the sling removal and urethropexy.On (b)(6) 2019, the patient presented to pelvic health physical therapy pt with primary complaints and limitations with pelvic pain, vaginal pain, and groin pain.She also reported painful urination urethral and bladder pain; 70% of the time, fecal incontinence 1x month with an urge, urinary incontinence completely emptying of bladder with walking, nocturia 1-2x/night, and frequency going every hour during the day.The patient was centrally sensitized with b multi-angle movement, severe reactivity upon light palpation through b adductors, severe pain upon palpation of all layers of pelvic floor muscles pfm, observing moderate amounts of urine leakage with request to cough.The physical therapist recommended pre-habilitation pt to assist in desensitizing her myofascial and neurological system to set her up for successful surgery and recovery.On (b)(6) 2021, the patient was seen in a telemedicine appointment for fecal incontinence, sharp and excruciating bilateral pain slightly more on the right, and significant bladder burning.Since the surgery, the patient had not been able to have intercourse which was extremely painful.Moreover, she also developed numbness in both of her buttocks especially when sitting, and that numbness was around her rectum.The patient had fecal incontinence, but also had constipation.She has nocturia x2.Reportedly, she had significant hypersensitivity in the perineal area.In (b)(6) 2018, the patient started considering mesh removal but the physicians she saw said that the entire mesh cannot be removed so patient did not want to pursue this surgery as she felt very strongly that the entire mesh needs to be removed.The patient then wanted to have physical therapy but at that time she could not afford it.The patient felt that she was completely debilitated since implantation of mesh.The assessment included spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.The patient was advised that she has significant pudendal and obturator neuralgia caused by obtryx mesh.She had most likely developed significant spasm of the obturator internus muscle which put pressure on her pudendal and obturator nerves.She has symptoms of obturator neuralgia such as groin pain as well as symptoms of pudendal neuralgia such as rectal numbness with sitting.She also has allodynia which is consistent with neuropathic pain.Additionally, she has symptoms of pelvic floor muscle spasm such as nocturia and pain with intercourse.We have discussed treatment options and were going to proceed with removal of the entire obtryx mesh as well as bilateral pudendal nerve block and botulinum toxin a injection into pelvic floor muscles.If there is no improvement, she may be a candidate for bilateral pudendal neurolysis.On (b)(6) 2021, the patient presented for her pre-surgical counselling.She was scheduled to undergo removal of obtryx mesh - both vaginal part and bilateral groin, bilateral pudendal nerve block and botox injection to pelvic floor muscles.She was complaining of severe perineal/vulvar and vaginal pain.She had significant hypersensitivity in the clitoris and labia.Reportedly, the patient stated that she was not able to wear any underwear because for this burning hypersensitivity pain.She also stated that she was experiencing significant urinary incontinence.Furthermore, it was observed that there was bilateral lower back tenderness, bilateral lower abdominal tenderness, very significant bilateral spasm of the pelvic floor muscles especially obturator internus muscles bilaterally, and significant sensitivity to touch in the clitoris, bilateral labia, and the inner thighs.During assessment, it was noted that the patient had allodynia, spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.During counseling, the physician had mentioned that the patent will most likely need repeat injections of botox to the pelvic floor muscles together with pudendal nerve blocks every three months for many years ahead.On (b)(6) 2021, the patient underwent vaginal mesh removal, groin mesh removal, pudendal nerve block, botox injection into pelvic floor, kelly plication, and osteotomy of pubic bone procedure for the pre-operative diagnoses of complication of implanted vaginal mesh, spastic pelvic floor syndrome, pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome type ii intraoperative findings included that the transobturator suburethral sling was densely attached to the medial aspect of the obturator foramen bilaterally, and there was a significant bilateral spasm of pelvic floor muscles.The mesh was identified and was very carefully dissected off the vaginal epithelium as well as the urethra and the bladder using sharp and blunt dissection.The dissection continued all the way behind the inferior ramus of the pubic bone on both sides.Approximately 4 cm incision was then made in the left genitofemoral crease and dissection was done until the fascia of the adductor muscles was identified.Fascia was then cut and after lengthy search the arm of the polypropylene mesh was identified.The mesh was found in the muscles of the groin in the area of expected placement of the mesh.It was then followed laterally until the cut end of it was identified.The mesh was then followed medially.The mesh was found to be very densely adherent to the dorsal side of the pubic bone medial to the obturator foramen.Using osteotome, a small piece of the pubic bone was removed allowing for complete removal of the transobturator mesh.A similar approach was taken on the right side for the right side of the mesh.The mesh was then removed completely from the right side and the vagina.This signifies that the entire polypropylene mesh was removed from the patient.The procedure was completed without complications.The patient was admitted for postoperative medical management postoperatively, the patient reported postoperative pain, with pain rated around 5/10, however, earlier it was rated up to 10/10, and she had some left leg tingling.The excised mesh and adherent tissue were submitted for pathology.The final pathologic diagnosis or gross examination was foreign mesh material with no significant pathologic changes.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a transobturator vaginal sling and cystoscopy procedure performed on (b)(6) 2018.For the treatment of stress urinary incontinence (sui).On (b)(6) 2018, the patient mentioned that she still had residual sui for 7 weeks post sling procedure, with symptoms that included dyspareunia, embarrassed, incontinence of urine, pelvic pain, and sexual dysfunction.Furthermore, the symptoms were exacerbated by coughing, sneezing, laughing, exercise, heavy lifting, and full bladder.In addition, pertinent medical history included recurrent urinary tract infections, kidney stones, rectocele, pelvic pain, stress urinary incontinence, and hematuria.Also, she had undergone bladder scan, and urine culture.Exam revealed good healing, the urethra was quite stable, but there was a fair amount of leakage with cough.The assessment was stress urinary incontinence.The patient was advised that she had tremendous leakage pre-op and the mesh sling has not solved it, so options included a bulking agent followed by an autologous pv sling.The patient was interested but her insurance would not cover coaptite.Urinalysis showed pyuria, and a culture was submitted.Results were not included in the medical records provided.On (b)(6) 2019, the patient presented for a second opinion for mixed incontinence, ongoing sui, frequency, bilateral groin pain, and dyspareunia.Her sui's onset was 10 years ago that got worse over time.Also, she had nocturia once to twice onset for about 9 months ago, and urgency only at night.Moreover, she only drank 1 serving of caffeine daily.The patient also experienced burning sensation from time to time, and only had a treatment once for urinary tract infection (uti).She stated that she's not sexually active due to pain which was not the case prior to her sling.Reportedly, there was no improvement on prior myrbetriq trial.She had 2 kidney stones with the last one on (b)(6) 2018, and had genital herpes which was treated with acyclovir, however, she had an outbreak a month ago.During the review of systems, the patient had mentioned that she had weight gain, dizziness, joint pain and back pain.Also, the patient had painful urination, frequent, urgent urination, incontinence, incomplete bladder emptying, nighttime urination, sexual dysfunction, vaginal pain, and vaginal burning.Exam revealed severe urethral hypermobility, perfuse cough stress test with no mesh exposed, and sling at mid-urethra and was tender.Reportedly, there was levator tenderness on the right, and pain at the inner aspect of muscles.Treatment options included sling excision and subsequent autologous pv sling, but the patient was advised she would need pelvic floor physical therapy (pfpt) and urodynamics study (uds) prior.On (b)(6) 2019, cystoscopy, uds, and complete urinalysis were performed.The patient was experiencing pelvic, perineal, vaginal and groin pain, stress incontinence, and mixed incontinence ever since she had the transobturator sling procedure.No abnormalities were noted on cystoscopy.Uds revealed abdominal leak point pressure (allp) of 58-128 cm h2o and pseudodyssynergia consistent with dysfunctional voiding.The assessment was pelvic and perineal pain, stress incontinence, and mixed incontinence.The physician had a discussion with the patient about proceeding with sling removal and to continue pelvic floor physical therapy (pfpt).The patient also understood that sui may still persist or worsen, and pain could not be resolved with the treatment.However, she still wanted to proceed with the sling removal and urethropexy.On (b)(6) 2019, the patient presented to pelvic health physical therapy (pt) with primary complaints and limitations with pelvic pain, vaginal pain, and groin pain.She also reported painful urination (urethral and bladder pain; 70% of the time), fecal incontinence 1x month with an urge, urinary incontinence (completely emptying of bladder with walking), nocturia 1-2x/night, and frequency (going every hour during the day).The patient was centrally sensitized with b multi-angle movement, severe reactivity upon light palpation through b adductors, severe pain upon palpation of all layers of pelvic floor muscles (pfm), observing moderate amounts of urine leakage with request to cough.The physical therapist recommended pre-habilitation pt to assist in desensitizing her myofascial and neurological system to set her up for successful surgery and recovery.On (b)(6) 2021, the patient was seen in a telemedicine appointment for fecal incontinence, sharp and excruciating bilateral pain slightly more on the right, and significant bladder burning.Since the surgery, the patient had not been able to have intercourse which was extremely painful.Moreover, she also developed numbness in both of her buttocks especially when sitting, and that numbness was around her rectum.The patient had fecal incontinence, but also had constipation.She has nocturia x2.Reportedly, she had significant hypersensitivity in the perineal area.In (b)(6) 2018, the patient started considering mesh removal but the physicians she saw said that the entire mesh cannot be removed so patient did not want to pursue this surgery as she felt very strongly that the entire mesh needs to be removed.The patient then wanted to have physical therapy but at that time she could not afford it.The patient felt that she was completely debilitated since implantation of mesh.The assessment included spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.The patient was advised that she has significant pudendal and obturator neuralgia caused by obtryx mesh.She had most likely developed significant spasm of the obturator internus muscle which put pressure on her pudendal and obturator nerves.She has symptoms of obturator neuralgia such as groin pain as well as symptoms of pudendal neuralgia such as rectal numbness with sitting.She also has allodynia which is consistent with neuropathic pain.Additionally, she has symptoms of pelvic floor muscle spasm such as nocturia and pain with intercourse.We have discussed treatment options and were going to proceed with removal of the entire obtryx mesh as well as bilateral pudendal nerve block and botulinum toxin a injection into pelvic floor muscles.If there is no improvement, she may be a candidate for bilateral pudendal neurolysis.On (b)(6) 2021, the patient presented for her pre-surgical counselling.She was scheduled to undergo removal of obtryx mesh - both vaginal part and bilateral groin, bilateral pudendal nerve block and botox injection to pelvic floor muscles.She was complaining of severe perineal/vulvar and vaginal pain.She had significant hypersensitivity in the clitoris and labia.Reportedly, the patient stated that she was not able to wear any underwear because for this burning hypersensitivity pain.She also stated that she was experiencing significant urinary incontinence.Furthermore, it was observed that there was bilateral lower back tenderness, bilateral lower abdominal tenderness, very significant bilateral spasm of the pelvic floor muscles especially obturator internus muscles bilaterally, and significant sensitivity to touch in the clitoris, bilateral labia, and the inner thighs.During assessment, it was noted that the patient had allodynia, spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.During counseling, the physician had mentioned that the patent will most likely need repeat injections of botox to the pelvic floor muscles together with pudendal nerve blocks every three months for many years ahead.On (b)(6) 2021, the patient underwent vaginal mesh removal, groin mesh removal, pudendal nerve block, botox injection into pelvic floor, kelly plication, and osteotomy of pubic bone procedure for the pre-operative diagnoses of complication of implanted vaginal mesh, spastic pelvic floor syndrome, pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome type ii intraoperative findings included that the transobturator suburethral sling was densely attached to the medial aspect of the obturator foramen bilaterally, and there was a significant bilateral spasm of pelvic floor muscles.The mesh was identified and was very carefully dissected off the vaginal epithelium as well as the urethra and the bladder using sharp and blunt dissection.The dissection continued all the way behind the inferior ramus of the pubic bone on both sides.Approximately 4 cm incision was then made in the left genitofemoral crease and dissection was done until the fascia of the adductor muscles was identified.Fascia was then cut and after lengthy search the arm of the polypropylene mesh was identified.The mesh was found in the muscles of the groin in the area of expected placement of the mesh.It was then followed laterally until the cut end of it was identified.The mesh was then followed medially.The mesh was found to be very densely adherent to the dorsal side of the pubic bone medial to the obturator foramen.Using osteotome, a small piece of the pubic bone was removed allowing for complete removal of the transobturator mesh.A similar approach was taken on the right side for the right side of the mesh.The mesh was then removed completely from the right side and the vagina.This signifies that the entire polypropylene mesh was removed from the patient.The procedure was completed without complications.The patient was admitted for postoperative medical management postoperatively, the patient reported postoperative pain, with pain rated around 5/10, however, earlier it was rated up to 10/10, and she had some left leg tingling.The excised mesh and adherent tissue were submitted for pathology.The final pathologic diagnosis (gross examination) was foreign mesh material with no significant pathologic changes.Additional received on july 15, 2022.On (b)(6) 2022, the patient visited to discuss surgery, history of sling surgery and complained of incontinence.During the visit, the patient had bladder scan and urinalysis without micro.Although sling removal was performed on (b)(6) 2021, patient reported incontinence.Physical examination in vagina showed bilateral levator severely ttp and tight.Physician's note stated pudendal neuralgia, ongoing sui, nocturia, severe dyspareunia, not sexually active and no meds for oab.The patient did pelvic floor physical therapy four times a month; wears diapers and changes every 4 minutes; and voids every 2 hours.Lastly, discussion was made regarding uds appointment on (b)(6) 2022.

Manufacturer Narrative

Correction: block g2: report source - consumer only.Block b3 date of event: the exact event onset date is unknown; however, it was reported that the patient had recurrent symptom on (b)(6) 2018.Block e1: this event was reported by the patient's legal representation.Dr.(b)(6).Block h6: patient codes e1310, e2328, e1309, e0402, e2401, e0123, e2330, e2112, e1405 and e2101 capture the reportable events of infection, urinary tract, obstruction, ureter/urethra (kidney stones), urinary retention (incomplete bladder emptying), hypersensitivity, injury, nos (not otherwise specified) for genital herpes, gerd (gastroesophageal reflux disease), subacute myoclonic spinal neuronitis, nerve damage (obturator neuralgia, pudendal neuralgia), pain (pelvic pain, groin pain, perineal pain, vaginal pain, joint pain, back pain, hip pain, bladder pain, allodynia), pain, intraoperative (acute), dyspareunia and adhesion respectively.Impact codes f1202, f1903, f19, f23, f22, and f2303 capture the reportable events of disability (debilitated), device explantation (removal of the vaginal part of sub-urethral transobturator sling, bilateral groin mesh removal), surgical intervention (osteotomy of left and pubic bone, kelly plication), unexpected medical intervention (pudendal nerve block, urodynamic study), unexpected diagnostic intervention (bladder scan, urine culture, urinalysis, cystoscopy), and medication required (botox injection to pelvic floor muscles) respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Additional information: block b5, d6b.Correction: block g2: report source - consumer only.Block b3 date of event: the exact event onset date is unknown; however, it was reported that the patient had recurrent symptom on may 4, 2018.Block e1: this event was reported by the patient's legal representation.Dr.(b)(6).Block h6: patient codes e1310, e2328, e1309, e0402, e2401, e0123, e2330, e2112, e1405 and e2101 capture the reportable events of infection, urinary tract, obstruction, ureter/urethra (kidney stones), urinary retention (incomplete bladder emptying), hypersensitivity, injury, nos (not otherwise specified) for genital herpes, gerd (gastroesophageal reflux disease), subacute myoclonic spinal neuronitis, nerve damage (obturator neuralgia, pudendal neuralgia), pain (pelvic pain, groin pain, perineal pain, vaginal pain, joint pain, back pain, hip pain, bladder pain, allodynia), pain, intraoperative (acute), dyspareunia and adhesion respectively.Impact codes f1202, f1903, f19, f23, f22, and f2303 capture the reportable events of disability (debilitated), device explantation (removal of the vaginal part of sub-urethral transobturator sling, bilateral groin mesh removal), surgical intervention (osteotomy of left and pubic bone, kelly plication), unexpected medical intervention (pudendal nerve block, urodynamic study), unexpected diagnostic intervention (bladder scan, urine culture, urinalysis, cystoscopy), and medication required (botox injection to pelvic floor muscles) respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a transobturator vaginal sling and cystoscopy procedure performed on (b)(6) 2018.For the treatment of stress urinary incontinence (sui).On (b)(6) 2018, the patient mentioned that she still had residual sui for 7 weeks post sling procedure, with symptoms that included dyspareunia, embarrassed, incontinence of urine, pelvic pain, and sexual dysfunction.Furthermore, the symptoms were exacerbated by coughing, sneezing, laughing, exercise, heavy lifting, and full bladder.In addition, pertinent medical history included recurrent urinary tract infections, kidney stones, rectocele, pelvic pain, stress urinary incontinence, and hematuria.Also, she had undergone bladder scan, and urine culture.Exam revealed good healing, the urethra was quite stable, but there was a fair amount of leakage with cough.The assessment was stress urinary incontinence.The patient was advised that she had tremendous leakage pre-op and the mesh sling has not solved it, so options included a bulking agent followed by an autologous pv sling.The patient was interested but her insurance would not cover coaptite.Urinalysis showed pyuria, and a culture was submitted.Results were not included in the medical records provided.On (b)(6) 2019, the patient presented for a second opinion for mixed incontinence, ongoing sui, frequency, bilateral groin pain, and dyspareunia.Her sui's onset was 10 years ago thatgot worse over time.Also, she had nocturia once to twice onset for about 9 months ago, and urgency only at night.Moreover, she only drank 1 serving of caffeine daily.The patient also experienced burning sensation from time to time, and only had a treatment once for urinary tract infection (uti).She stated that she's not sexually active due to pain which was not the case prior to her sling.Reportedly, there was no improvement on prior myrbetriq trial.She had 2 kidney stones with the last one on november 2018, and had genital herpes which was treated with acyclovir, however, she had an outbreak a month ago.During the review of systems, the patient had mentioned that she had weight gain, dizziness, joint pain and back pain.Also, the patient had painful urination, frequent, urgent urination, incontinence, incomplete bladder emptying, nighttime urination, sexual dysfunction, vaginal pain, and vaginal burning.Exam revealed severe urethral hypermobility, perfuse cough stress test with no mesh exposed, and sling at mid-urethra and was tender.Reportedly, there was levator tenderness on the right, and pain at the inner aspect of muscles.Treatment options included sling excision and subsequent autologous pv sling, but the patient was advised she would need pelvic floor physical therapy (pfpt) and urodynamics study (uds) prior.On (b)(6) 2019, cystoscopy, uds, and complete urinalysis were performed.The patient was experiencing pelvic, perineal, vaginal and groin pain, stress incontinence, and mixed incontinence ever since she had the transobturator sling procedure.No abnormalities were noted on cystoscopy.Uds revealed abdominal leak point pressure (allp) of 58-128 cm h2o and pseudodyssenergia consistent with dysfunctional voiding.The assessment was pelvic and perineal pain, stress incontinence, and mixed incontinence.The physician had a discussion with the patient about proceeding with sling removal and to continue pelvic floor physical therapy (pfpt).The patient also understood that sui may still persist or worsen, and pain could not be resolved with the treatment.However, she still wanted to proceed with the sling removal and urethropexy.On (b)(6) 2019, the patient presented to pelvic health physical therapy (pt) with primary complaints and limitations with pelvic pain, vaginal pain, and groin pain.She also reported painful urination (urethral and bladder pain; 70% of the time), fecal incontinence 1x month with an urge, urinary incontinence (completely emptying of bladder with walking), nocturia 1-2x/night, and frequency (going every hour during the day).The patient was centrally sensitized with b multi-angle movement, severe reactivity upon light palpation through b adductors, severe pain upon palpation of all layers of pelvic floor muscles (pfm), observing moderate amounts of urine leakage with request to cough.The physical therapist recommended pre-habilitation pt to assist in desensitizing her myofascial and neurological system to set her up for successful surgery and recovery.On (b)(6) 2021, the patient was seen in a telemedicine appointment for fecal incontinence, sharp and excruciating bilateral pain slightly more on the right, and significant bladder burning.Since the surgery, the patient had not been able to have intercourse which was extremely painful.Moreover, she also developed numbness in both of her buttocks especially when sitting, and that numbness was around her rectum.The patient had fecal incontinence, but also had constipation.She has nocturia x2.Reportedly, she had significant hypersensitivity in the perineal area.In august 2018, the patient started considering mesh removal but the physicians she saw said that the entire mesh cannot be removed so patient did not want to pursue this surgery as she felt very strongly that the entire mesh needs to be removed.The patient then wanted to have physical therapy but at that time she could not afford it.The patient felt that she was completely debilitated since implantation of mesh.The assessment included spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.The patient was advised that she has significant pudendal and obturator neuralgia caused by obtryx mesh.She had most likely developed significant spasm of the obturator internus muscle which put pressure on her pudendal and obturator nerves.She has symptoms of obturator neuralgia such as groin pain as well as symptoms of pudendal neuralgia such as rectal numbness with sitting.She also has allodynia which is consistent with neuropathic pain.Additionally, she has symptoms of pelvic floor muscle spasm such as nocturia and pain with intercourse.We have discussed treatment options and were going to proceed with removal of the entire obtryx mesh as well as bilateral pudendal nerve block and botulinum toxin a injection into pelvic floor muscles.If there is no improvement, she may be a candidate for bilateral pudendal neurolysis.On (b)(6) 2021, the patient presented for her pre-surgical counselling.She was scheduled to undergo removal of obtryx mesh - both vaginal part and bilateral groin, bilateral pudendal nerve block and botox injection to pelvic floor muscles.She was complaining of severe perineal/vulvar and vaginal pain.She had significant hypersensitivity in the clitoris and labia.Reportedly, the patient stated that she was not able to wear any underwear because for this burning hypersensitivity pain.She also stated that she was experiencing significant urinary incontinence.Furthermore, it was observed that there was bilateral lower back tenderness, bilateral lower abdominal tenderness, very significant bilateral spasm of the pelvic floor muscles especially obturator internus muscles bilaterally, and significant sensitivity to touch in the clitoris, bilateral labia, and the inner thighs.During assessment, it was noted that the patient had allodynia, spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.During counseling, the physician had mentioned that the patent will most likely need repeat injections of botox to the pelvic floor muscles together with pudendal nerve blocks every three months for many years ahead.On (b)(6) 2021, the patient underwent vaginal mesh removal, groin mesh removal, pudendal nerve block, botox injection into pelvic floor, kelly plication, and osteotomy of pubic bone procedure for the pre-operative diagnoses of complication of implanted vaginal mesh, spastic pelvic floor syndrome, pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome type ii intraoperative findings included that the transobturator suburethral sling was densely attached to the medial aspect of the obturator foramen bilaterally, and there was a significant bilateral spasm of pelvic floor muscles.The mesh was identified and was very carefully dissected off the vaginal epithelium as well as the urethra and the bladder using sharp and blunt dissection.The dissection continued all the way behind the inferior ramus of the pubic bone on both sides.Approximately 4 cm incision was then made in the left genitofemoral crease and dissection was done until the fascia of the adductor muscles was identified.Fascia was then cut and after lengthy search the arm of the polypropylene mesh was identified.The mesh was found in the muscles of the groin in the area of expected placement of the mesh.It was then followed laterally until the cut end of it was identified.The mesh was then followed medially.The mesh was found to be very densely adherent to the dorsal side of the pubic bone medial to the obturator foramen.Using osteotome, a small piece of the pubic bone was removed allowing for complete removal of the transobturator mesh.A similar approach was taken on the right side for the right side of the mesh.The mesh was then removed completely from the right side and the vagina.This signifies that the entire polypropylene mesh was removed from the patient.The procedure was completed without complications.The patient was admitted for postoperative medical management postoperatively, the patient reported postoperative pain, with pain rated around 5/10, however, earlier it was rated up to 10/10, and she had some left leg tingling.The excised mesh and adherent tissue were submitted for pathology.The final pathologic diagnosis (gross examination) was foreign mesh material with no significant pathologic changes.Additional received on july 15, 2022.On (b)(6) 2022, the patient visited to discuss surgery, history of sling surgery and complained of incontinence.During the visit, the patient had bladder scan and urinalysis without micro.Although sling removal was performed on (b)(6) 2021, patient reported incontinence.Physical examination in vagina showed bilateral levator severely ttp and tight.Physician's note stated pudendal neuralgia, ongoing sui, nocturia, severe dyspareunia, not sexually active and no meds for oab.The patient did pelvic floor physical therapy four times a month; wears diapers and changes every 4 minutes; and voids every 2 hours.Lastly, discussion was made regarding uds appointment on (b)(6) 2022.Additional information received on september 23, 2022.The patient presented to physical therapy with urinary and bowel incontinence (wearing diapers), vaginal spasms, pudendal neuralgia with groin pain following mesh removal surgery in 2021.The patient was going to have another surgery for incontinence sling which was still to be scheduled.The patient was walking with cane due to left leg giving out due to pain in the groin area.The patient reported that her muscles spasms started with mesh removal which was reportedly better with botox.It was reported that the patient needed an additional botox but she decided to put it off until the new year.The patient experienced "acid feeling" on skin between her legs with increased walking.She reportedly was not able to sit for any length of time.The patient reportedly to have not performed intercourse since 2018.On (b)(6) 2021, the patient has developed a severe case of being raw.She felt like acid was being poured on her.She was not sure what was causing the flare up.The patient was seen and examined if a catheter needs to be inserted.The patient was seen for pelvic health physical therapy to address concerns regarding urinary incontinence and pelvic pain.After patient needing to cancel several scheduled appointments due to increased symptoms, multiple attempts to contact the patient were made but have gone unanswered.The health care providers were unable to assess the patient's current understanding of the prognosis due to not completing plan of care and they were unable to assess the patient's current understanding of home exercises program due to not completing plan of care.The patient reportedly chose to discontinue therapy and was self-discharged from physical therapy on december 29, 2021.On may 24, 2022, the patient was seen and it was established that the patient had a history of persistent stress urinary incontinence after transobturator tape (tot) sling on march 2018.The patient was seen in 2019 for a second opinion and did not follow up.The patient since had extensive sling removal surgery on june 2021 due to pudendal neuralgia.The patient is currently experiencing an ongoing stress urinary incontinence.The patient also reported nocturia.She wore diapers and changed every 45 minutes.The patient also reported to void every two hours.The patient was also experiencing sever dyspareunia and was not sexually active.Upon examination, the patient's bilateral levator was severely ttp and moderate urethral hypermobility was noted.Marshall-bonney test was positive.It was then concluded that the patient needed cystoscopy and urodynamic studies.On (b)(6) 2022, the patient still has an ongoing stress urinary incontinence.The patient underwent multiple pain exposure in physical therapy (pept) sessions which was not helpful after surgery.The patient's cystoscopy revealed negative results.Urodynamic study of the patient revealed multiple stress urinary incontinence low lpp and stress induced do.The risks and success rates of a pelvic sling were discussed with patient and it was advised that a bulking agent may be necessary if stress urinary incontinence persists.The patient currently has travel plans and wanted to wait until after october.The patient was referred to pain exposure in physical therapy (pept) for now.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a transobturator vaginal sling and cystoscopy procedure performed on (b)(6) 2018.For the treatment of stress urinary incontinence (sui).On (b)(6) 2018, the patient mentioned that she still had residual sui for 7 weeks post sling procedure, with symptoms that included dyspareunia, embarrassed, incontinence of urine, pelvic pain, and sexual dysfunction.Furthermore, the symptoms were exacerbated by coughing, sneezing, laughing, exercise, heavy lifting, and full bladder.In addition, pertinent medical history included recurrent urinary tract infections, kidney stones, rectocele, pelvic pain, stress urinary incontinence, and hematuria.Also, she had undergone bladder scan, and urine culture.Exam revealed good healing, the urethra was quite stable, but there was a fair amount of leakage with cough.The assessment was stress urinary incontinence.The patient was advised that she had tremendous leakage pre-op and the mesh sling has not solved it, so options included a bulking agent followed by an autologous pv sling.The patient was interested but her insurance would not cover coaptite.Urinalysis showed pyuria, and a culture was submitted.Results were not included in the medical records provided.On (b)(6) 2019, the patient presented for a second opinion for mixed incontinence, ongoing sui, frequency, bilateral groin pain, and dyspareunia.Her sui's onset was 10 years ago that got worse over time.Also, she had nocturia once to twice onset for about 9 months ago, and urgency only at night.Moreover, she only drank 1 serving of caffeine daily.The patient also experienced burning sensation from time to time, and only had a treatment once for urinary tract infection (uti).She stated that she's not sexually active due to pain which was not the case prior to her sling.Reportedly, there was no improvement on prior myrbetriq trial.She had 2 kidney stones with the last one on (b)(6) 2018, and had genital herpes which was treated with acyclovir, however, she had an outbreak a month ago.During the review of systems, the patient had mentioned that she had weight gain, dizziness, joint pain and back pain.Also, the patient had painful urination, frequent, urgent urination, incontinence, incomplete bladder emptying, nighttime urination, sexual dysfunction, vaginal pain, and vaginal burning.Exam revealed severe urethral hypermobility, perfuse cough stress test with no mesh exposed, and sling at mid-urethra and was tender.Reportedly, there was levator tenderness on the right, and pain at the inner aspect of muscles.Treatment options included sling excision and subsequent autologous pv sling, but the patient was advised she would need pelvic floor physical therapy (pfpt) and urodynamics study (uds) prior.On (b)(6) 2019, cystoscopy, uds, and complete urinalysis were performed.The patient was experiencing pelvic, perineal, vaginal and groin pain, stress incontinence, and mixed incontinence ever since she had the transobturator sling procedure.No abnormalities were noted on cystoscopy.Uds revealed abdominal leak point pressure (allp) of 58-128 cm h2o and pseudodyssynergia consistent with dysfunctional voiding.The assessment was pelvic and perineal pain, stress incontinence, and mixed incontinence.The physician had a discussion with the patient about proceeding with sling removal and to continue pelvic floor physical therapy (pfpt).The patient also understood that sui may still persist or worsen, and pain could not be resolved with the treatment.However, she still wanted to proceed with the sling removal and urethropexy.On (b)(6) 2019, the patient presented to pelvic health physical therapy (pt) with primary complaints and limitations with pelvic pain, vaginal pain, and groin pain.She also reported painful urination (urethral and bladder pain; 70% of the time), fecal incontinence 1x month with an urge, urinary incontinence (completely emptying of bladder with walking), nocturia 1-2x/night, and frequency (going every hour during the day).The patient was centrally sensitized with b multi-angle movement, severe reactivity upon light palpation through b adductors, severe pain upon palpation of all layers of pelvic floor muscles (pfm), observing moderate amounts of urine leakage with request to cough.The physical therapist recommended pre-habilitation pt to assist in desensitizing her myofascial and neurological system to set her up for successful surgery and recovery.On (b)(6) 2021, the patient was seen in a telemedicine appointment for fecal incontinence, sharp and excruciating bilateral pain slightly more on the right, and significant bladder burning.Since the surgery, the patient had not been able to have intercourse which was extremely painful.Moreover, she also developed numbness in both of her buttocks especially when sitting, and that numbness was around her rectum.The patient had fecal incontinence, but also had constipation.She has nocturia x2.Reportedly, she had significant hypersensitivity in the perineal area.In (b)(6) 2018, the patient started considering mesh removal but the physicians she saw said that the entire mesh cannot be removed so patient did not want to pursue this surgery as she felt very strongly that the entire mesh needs to be removed.The patient then wanted to have physical therapy but at that time she could not afford it.The patient felt that she was completely debilitated since implantation of mesh.The assessment included spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.The patient was advised that she has significant pudendal and obturator neuralgia caused by obtryx mesh.She had most likely developed significant spasm of the obturator internus muscle which put pressure on her pudendal and obturator nerves.She has symptoms of obturator neuralgia such as groin pain as well as symptoms of pudendal neuralgia such as rectal numbness with sitting.She also has allodynia which is consistent with neuropathic pain.Additionally, she has symptoms of pelvic floor muscle spasm such as nocturia and pain with intercourse.We have discussed treatment options and were going to proceed with removal of the entire obtryx mesh as well as bilateral pudendal nerve block and botulinum toxin a injection into pelvic floor muscles.If there is no improvement, she may be a candidate for bilateral pudendal neurolysis.On (b)(6) 2021, the patient presented for her pre-surgical counselling.She was scheduled to undergo removal of obtryx mesh - both vaginal part and bilateral groin, bilateral pudendal nerve block and botox injection to pelvic floor muscles.She was complaining of severe perineal/vulvar and vaginal pain.She had significant hypersensitivity in the clitoris and labia.Reportedly, the patient stated that she was not able to wear any underwear because for this burning hypersensitivity pain.She also stated that she was experiencing significant urinary incontinence.Furthermore, it was observed that there was bilateral lower back tenderness, bilateral lower abdominal tenderness, very significant bilateral spasm of the pelvic floor muscles especially obturator internus muscles bilaterally, and significant sensitivity to touch in the clitoris, bilateral labia, and the inner thighs.During assessment, it was noted that the patient had allodynia, spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.During counseling, the physician had mentioned that the patent will most likely need repeat injections of botox to the pelvic floor muscles together with pudendal nerve blocks every three months for many years ahead.On (b)(6) 2021, the patient underwent vaginal mesh removal, groin mesh removal, pudendal nerve block, botox injection into pelvic floor, kelly plication, and osteotomy of pubic bone procedure for the pre-operative diagnoses of complication of implanted vaginal mesh, spastic pelvic floor syndrome, pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome type ii intraoperative findings included that the transobturator suburethral sling was densely attached to the medial aspect of the obturator foramen bilaterally, and there was a significant bilateral spasm of pelvic floor muscles.The mesh was identified and was very carefully dissected off the vaginal epithelium as well as the urethra and the bladder using sharp and blunt dissection.The dissection continued all the way behind the inferior ramus of the pubic bone on both sides.Approximately 4 cm incision was then made in the left genitofemoral crease and dissection was done until the fascia of the adductor muscles was identified.Fascia was then cut and after lengthy search the arm of the polypropylene mesh was identified.The mesh was found in the muscles of the groin in the area of expected placement of the mesh.It was then followed laterally until the cut end of it was identified.The mesh was then followed medially.The mesh was found to be very densely adherent to the dorsal side of the pubic bone medial to the obturator foramen.Using osteotome, a small piece of the pubic bone was removed allowing for complete removal of the transobturator mesh.A similar approach was taken on the right side for the right side of the mesh.The mesh was then removed completely from the right side and the vagina.This signifies that the entire polypropylene mesh was removed from the patient.The procedure was completed without complications.The patient was admitted for postoperative medical management postoperatively, the patient reported postoperative pain, with pain rated around 5/10, however, earlier it was rated up to 10/10, and she had some left leg tingling.The excised mesh and adherent tissue were submitted for pathology.The final pathologic diagnosis (gross examination) was foreign mesh material with no significant pathologic changes.Additional received on july 15, 2022.On (b)(6) 2022, the patient visited to discuss surgery, history of sling surgery and complained of incontinence.During the visit, the patient had bladder scan and urinalysis without micro.Although sling removal was performed on (b)(6) 2021, patient reported incontinence.Physical examination in vagina showed bilateral levator severely ttp and tight.Physician's note stated pudendal neuralgia, ongoing sui, nocturia, severe dyspareunia, not sexually active and no meds for oab.The patient did pelvic floor physical therapy four times a month; wears diapers and changes every 4 minutes; and voids every 2 hours.Lastly, discussion was made regarding uds appointment on (b)(6) 2022.Additional information received on september 23, 2022: on (b)(6) 2021, the patient reported of urinary and bowel incontinence (wearing diapers), vaginal spasms, pudendal neuralgia with groin pain following mesh removal surgery in 2021.The patient was going to have another surgery for incontinence sling which was still to be scheduled.The patient was walking with cane due to left leg giving out due to pain in the groin area.The patient reported that her muscles spasms started with mesh removal which was reportedly better with botox.It was reported that the patient needed an additional botox but she decided to put it off until the new year.The patient experienced "acid feeling" on skin between her legs with increased walking.She reportedly was not able to sit for any length of time.The patient reportedly to have not performed intercourse since 2018.On (b)(6) 2021, the patient has developed a severe case of being raw.Shee felt like acid was being poured on her.She was not sure what was causing the flare up.The patient was seen and examined if a catheter needs to be inserted.The patient was seen for pelvic health physical therapy to address concerns regarding urinary incontinence and pelvic pain.After patient needing to cancel several scheduled appointments due to increased symptoms, multiple attempts to contact the patient was made but have gone unanswered.The health care providers were unable to assess the patient's current understanding of the prognosis due to not completing plan of care and they were unable to assess the patient's current understanding of home exercises program due to not completing plan of care.The patient was choosing to discontinue therapy at this time.On (b)(6) 2022, the patient was seen and it was established that the patient had a history of persistent stress urinary incontinence after transobturator tape (tot) sling on (b)(6) 2018.The patient was seen in 2019 for a second opinion then lost to follow up.The patient since had extensive sling removal surgery on (b)(6) 2021 due to pudendal neuralgia.The patient is currently experiencing an ongoing stress urinary incontinence.The patient also reported nocturia.She wore diapers and changed every 45 minutes.The patient also reported to void every two hours.The patient was also experiencing sever dyspareunia and was not sexually active.Upon examination, the patient's bilateral levator was severely ttp and moderate urethral hypermobility was noted.Marshall-bonney test was positive.It was then concluded that the patient needed cystoscopy and urodynamic studies.On (b)(6) 2022, the patient still has an ongoing stress urinary incontinence.The patient underwent multiple pain exposure in physical therapy (pept) sessions which was not helpful after surgery.The patient's cystoscopy revealed negative results.Urodynamic study of the patient revealed multiple stress urinary incontinence low lpp and stress induced do.The risks and success rates of a pelvic sling were discussed with patient, and it was advised that a bulking agent may be necessary if stress urinary incontinence persists.The patient currently has travel plans and wanted to wait until after (b)(6).The patient was referred to pain exposure in physical therapy (pept) for now.Additional information received on november 16, 2022: the patient was examined to establish care on (b)(6) 2021, at the clinic.The patient was reportedly diagnosed with urinary incontinence and gastroesophageal reflux disease without esophagitis.The patient has also just had a recent appointment with a cardiologist due to some chest pain and a burning feeling that came on after eating.The patient was directed to an internal medicine specialist to begin treatment since it was believed that the problem may be gastrointestinal in nature.The patient was then told to start taking omeprazole 40 mg per day.The patient specifically mentioned bowel incontinence as one of her several problems following the sling insertion procedure.The patient also intended to get surgery to correct the issue.Otherwise, the patient denies having any other complaints during her visit.No headaches, chest pain, or shortness of breath.Review of systems: constitutional: negative for chills and fever.Respiratory: negative for cough and shortness of breath.Cardiovascular: negative for chest pain and leg swelling.Gastrointestinal: positive for heartburn.Negative for abdominal pain, constipation, nausea and vomiting.Musculoskeletal: negative for joint pain and myalgias.Neurological: negative for dizziness and headaches.Psychiatric/behavioral: negative for depression and suicidal ideas.

Manufacturer Narrative

Block b5 (narrative) has been updated based on the additional information received on november 16, 2022.Block b3 date of event: the exact event onset date is unknown; however, it was reported that the patient had recurrent symptom on (b)(6) 2018.Block e1: this event was reported by the patient's legal representation.Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Results physiotherapy (b)(6).Block h6: patient codes e1310, e2328, e1309, e0402, e2401, e0123, e2330, e2112, e1405 and e2101 capture the reportable events of infection, urinary tract, obstruction, ureter/urethra (kidney stones), urinary retention (incomplete bladder emptying), hypersensitivity, injury, nos (not otherwise specified) for genital herpes, gerd (gastroesophageal reflux disease), subacute myoclonic spinal neuronitis, nerve damage (obturator neuralgia, pudendal neuralgia), pain (pelvic pain, groin pain, perineal pain, vaginal pain, joint pain, back pain, hip pain, bladder pain, allodynia), pain, intraoperative (acute), dyspareunia and adhesion respectively.Impact codes f1202, f1903, f19, f23, f22, and f2303 capture the reportable events of disability (debilitated), device explantation (removal of the vaginal part of sub-urethral transobturator sling, bilateral groin mesh removal), surgical intervention (osteotomy of left and pubic bone, kelly plication), unexpected medical intervention (pudendal nerve block, urodynamic study), unexpected diagnostic intervention (bladder scan, urine culture, urinalysis, cystoscopy), and medication required (botox injection to pelvic floor muscles) respectively.

Manufacturer Narrative

Block h2: additional information blocks b5 (narrative) and h6 (patient code and impact code) has been updated based on the additional information on february 8, 2023.Block b3 date of event: the exact event onset date is unknown; however, it was reported that the patient had recurrent symptom on (b)(6) 2018.Block e1: this event was reported by the patient's legal representation.Dr.(b)(6).Block h6: imdrf patient codes e1310, e2328, e1309, e2401, e0123, e2330, e2112, e1405, e2101and e0402 capture the reportable events of infection, urinary tract, obstruction, ureter/urethra (kidney stones), urinary retention (incomplete bladder emptying), injury, nos (not otherwise specified) for genital herpes, gerd (gastroesophageal reflux disease), subacute myoclonic spinal neuronitis, nerve damage (obturator neuralgia, pudendal neuralgia), pain (pelvic pain, groin pain, perineal pain, vaginal pain, joint pain, back pain, hip pain, bladder pain, allodynia), pain, intraoperative (acute), dyspareunia, adhesion.Imdrf impact codes f1202, f1903, f19, f23, f22,, f2303 and f18 capture the reportable events of disability (debilitated), device explantation (removal of the vaginal part of sub-urethral transobturator sling, bilateral groin mesh removal), surgical intervention (osteotomy of left and pubic bone, kelly plication), unexpected medical intervention (pudendal nerve block, urodynamic study), unexpected diagnostic intervention (bladder scan, urine culture, urinalysis, cystoscopy), medication required (botox injection to pelvic floor muscles) and patient underwent physical therapy respectively.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a transobturator vaginal sling and cystoscopy procedure performed on (b)(6) 2018.For the treatment of stress urinary incontinence (sui).On (b)(6) 2018, the patient mentioned that she still had residual sui for 7 weeks post sling procedure, with symptoms that included dyspareunia, embarrassed, incontinence of urine, pelvic pain, and sexual dysfunction.Furthermore, the symptoms were exacerbated by coughing, sneezing, laughing, exercise, heavy lifting, and full bladder.In addition, pertinent medical history included recurrent urinary tract infections, kidney stones, rectocele, pelvic pain, stress urinary incontinence, and hematuria.Also, she had undergone bladder scan, and urine culture.Exam revealed good healing, the urethra was quite stable, but there was a fair amount of leakage with cough.The assessment was stress urinary incontinence.The patient was advised that she had tremendous leakage pre-op and the mesh sling has not solved it, so options included a bulking agent followed by an autologous pv sling.The patient was interested but her insurance would not cover coaptite.Urinalysis showed pyuria, and a culture was submitted.Results were not included in the medical records provided.On (b)(6) 2019, the patient presented for a second opinion for mixed incontinence, ongoing sui, frequency, bilateral groin pain, and dyspareunia.Her sui's onset was 10 years ago thatgot worse over time.Also, she had nocturia once to twice onset for about 9 months ago, and urgency only at night.Moreover, she only drank 1 serving of caffeine daily.The patient also experienced burning sensation from time to time, and only had a treatment once for urinary tract infection (uti).She stated that she's not sexually active due to pain which was not the case prior to her sling.Reportedly, there was no improvement on prior myrbetriq trial.She had 2 kidney stones with the last one on (b)(6) 2018, and had genital herpes which was treated with acyclovir, however, she had an outbreak a month ago.During the review of systems, the patient had mentioned that she had weight gain, dizziness, joint pain and back pain.Also, the patient had painful urination, frequent, urgent urination, incontinence, incomplete bladder emptying, nighttime urination, sexual dysfunction, vaginal pain, and vaginal burning.Exam revealed severe urethral hypermobility, perfuse cough stress test with no mesh exposed, and sling at mid-urethra and was tender.Reportedly, there was levator tenderness on the right, and pain at the inner aspect of muscles.Treatment options included sling excision and subsequent autologous pv sling, but the patient was advised she would need pelvic floor physical therapy (pfpt) and urodynamics study (uds) prior.On (b)(6) 2019, cystoscopy, uds, and complete urinalysis were performed.The patient was experiencing pelvic, perineal, vaginal and groin pain, stress incontinence, and mixed incontinence ever since she had the transobturator sling procedure.No abnormalities were noted on cystoscopy.Uds revealed abdominal leak point pressure (allp) of 58-128 cm h2o and pseudodyssenergia consistent with dysfunctional voiding.The assessment was pelvic and perineal pain, stress incontinence, and mixed incontinence.The physician had a discussion with the patient about proceeding with sling removal and to continue pelvic floor physical therapy (pfpt).The patient also understood that sui may still persist or worsen, and pain could not be resolved with the treatment.However, she still wanted to proceed with the sling removal and urethropexy.On (b)(6) 2019, the patient presented to pelvic health physical therapy (pt) with primary complaints and limitations with pelvic pain, vaginal pain, and groin pain.She also reported painful urination (urethral and bladder pain; 70% of the time), fecal incontinence 1x month with an urge, urinary incontinence (completely emptying of bladder with walking), nocturia 1-2x/night, and frequency (going every hour during the day).The patient was centrally sensitized with b multi-angle movement, severe reactivity upon light palpation through b adductors, severe pain upon palpation of all layers of pelvic floor muscles (pfm), observing moderate amounts of urine leakage with request to cough.The physical therapist recommended pre-habilitation pt to assist in desensitizing her myofascial and neurological system to set her up for successful surgery and recovery.On (b)(6) 2021, the patient was seen in a telemedicine appointment for fecal incontinence, sharp and excruciating bilateral pain slightly more on the right, and significant bladder burning.Since the surgery, the patient had not been able to have intercourse which was extremely painful.Moreover, she also developed numbness in both of her buttocks especially when sitting, and that numbness was around her rectum.The patient had fecal incontinence, but also had constipation.She has nocturia x2.Reportedly, she had significant hypersensitivity in the perineal area.In (b)(6) 2018, the patient started considering mesh removal but the physicians she saw said that the entire mesh cannot be removed so patient did not want to pursue this surgery as she felt very strongly that the entire mesh needs to be removed.The patient then wanted to have physical therapy but at that time she could not afford it.The patient felt that she was completely debilitated since implantation of mesh.The assessment included spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.The patient was advised that she has significant pudendal and obturator neuralgia caused by obtryx mesh.She had most likely developed significant spasm of the obturator internus muscle which put pressure on her pudendal and obturator nerves.She has symptoms of obturator neuralgia such as groin pain as well as symptoms of pudendal neuralgia such as rectal numbness with sitting.She also has allodynia which is consistent with neuropathic pain.Additionally, she has symptoms of pelvic floor muscle spasm such as nocturia and pain with intercourse.We have discussed treatment options and were going to proceed with removal of the entire obtryx mesh as well as bilateral pudendal nerve block and botulinum toxin a injection into pelvic floor muscles.If there is no improvement, she may be a candidate for bilateral pudendal neurolysis.On (b)(6) 2021, the patient presented for her pre-surgical counselling.She was scheduled to undergo removal of obtryx mesh - both vaginal part and bilateral groin, bilateral pudendal nerve block and botox injection to pelvic floor muscles.She was complaining of severe perineal/vulvar and vaginal pain.She had significant hypersensitivity in the clitoris and labia.Reportedly, the patient stated that she was not able to wear any underwear because for this burning hypersensitivity pain.She also stated that she was experiencing significant urinary incontinence.Furthermore, it was observed that there was bilateral lower back tenderness, bilateral lower abdominal tenderness, very significant bilateral spasm of the pelvic floor muscles especially obturator internus muscles bilaterally, and significant sensitivity to touch in the clitoris, bilateral labia, and the inner thighs.During assessment, it was noted that the patient had allodynia, spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.During counseling, the physician had mentioned that the patent will most likely need repeat injections of botox to the pelvic floor muscles together with pudendal nerve blocks every three months for many years ahead.On (b)(6) 2021, the patient underwent vaginal mesh removal, groin mesh removal, pudendal nerve block, botox injection into pelvic floor, kelly plication, and osteotomy of pubic bone procedure for the pre-operative diagnoses of complication of implanted vaginal mesh, spastic pelvic floor syndrome, pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome type ii intraoperative findings included that the transobturator suburethral sling was densely attached to the medial aspect of the obturator foramen bilaterally, and there was a significant bilateral spasm of pelvic floor muscles.The mesh was identified and was very carefully dissected off the vaginal epithelium as well as the urethra and the bladder using sharp and blunt dissection.The dissection continued all the way behind the inferior ramus of the pubic bone on both sides.Approximately 4 cm incision was then made in the left genitofemoral crease and dissection was done until the fascia of the adductor muscles was identified.Fascia was then cut and after lengthy search the arm of the polypropylene mesh was identified.The mesh was found in the muscles of the groin in the area of expected placement of the mesh.It was then followed laterally until the cut end of it was identified.The mesh was then followed medially.The mesh was found to be very densely adherent to the dorsal side of the pubic bone medial to the obturator foramen.Using osteotome, a small piece of the pubic bone was removed allowing for complete removal of the transobturator mesh.A similar approach was taken on the right side for the right side of the mesh.The mesh was then removed completely from the right side and the vagina.This signifies that the entire polypropylene mesh was removed from the patient.The procedure was completed without complications.The patient was admitted for postoperative medical management postoperatively, the patient reported postoperative pain, with pain rated around 5/10, however, earlier it was rated up to 10/10, and she had some left leg tingling.The excised mesh and adherent tissue were submitted for pathology.The final pathologic diagnosis (gross examination) was foreign mesh material with no significant pathologic changes.Additional received on july 15, 2022: on (b)(6) 2022, the patient visited to discuss surgery, history of sling surgery and complained of incontinence.During the visit, the patient had bladder scan and urinalysis without micro.Although sling removal was performed on (b)(6) 2021, patient reported incontinence.Physical examination in vagina showed bilateral levator severely ttp and tight.Physician's note stated pudendal neuralgia, ongoing sui, nocturia, severe dyspareunia, not sexually active and no meds for oab.The patient did pelvic floor physical therapy four times a month; wears diapers and changes every 4 minutes; and voids every 2 hours.Lastly, discussion was made regarding uds appointment on (b)(6) 2022.Additional information received on september 23, 2022: on (b)(6) 2021, the patient reported of urinary and bowel incontinence (wearing diapers), vaginal spasms, pudendal neuralgia with groin pain following mesh removal surgery in 2021.The patient was going to have another surgery for incontinence sling which was still to be scheduled.The patient was walking with cane due to left leg giving out due to pain in the groin area.The patient reported that her muscles spasms started with mesh removal which was reportedly better with botox.It was reported that the patient needed an additional botox but she decided to put it off until the new year.The patient experienced "acid feeling" on skin between her legs with increased walking.She reportedly was not able to sit for any length of time.The patient reportedly to have not performed intercourse since 2018.On (b)(6) 2021, the patient has developed a severe case of being raw.Shee felt like acid was being poured on her.She was not sure what was causing the flare up.The patient was seen and examined if a catheter needs to be inserted.The patient was seen for pelvic health physical therapy to address concerns regarding urinary incontinence and pelvic pain.After patient needing to cancel several scheduled appointments due to increased symptoms, multiple attempts to contact the patient was made but have gone unanswered.The health care providers were unable to assess the patient's current understanding of the prognosis due to not completing plan of care and they were unable to assess the patient's current understanding of home exercises program due to not completing plan of care.The patient was choosing to discontinue therapy at this time.On (b)(6) 2022, the patient was seen and it was established that the patient had a history of persistent stress urinary incontinence after transobturator tape (tot) sling on (b)(6) 2018.The patient was seen in 2019 for a second opinion then lost to follow up.The patient since had extensive sling removal surgery on (b)(6) 2021 due to pudendal neuralgia.The patient is currently experiencing an ongoing stress urinary incontinence.The patient also reported nocturia.She wore diapers and changed every 45 minutes.The patient also reported to void every two hours.The patient was also experiencing sever dyspareunia and was not sexually active.Upon examination, the patient's bilateral levator was severely ttp and moderate urethral hypermobility was noted.Marshall-bonney test was positive.It was then concluded that the patient needed cystoscopy and urodynamic studies.On (b)(6) 2022, the patient still has an ongoing stress urinary incontinence.The patient underwent multiple pain exposure in physical therapy (pept) sessions which was not helpful after surgery.The patient's cystoscopy revealed negative results.Urodynamic study of the patient revealed multiple stress urinary incontinence low lpp and stress induced do.The risks and success rates of a pelvic sling were discussed with patient, and it was advised that a bulking agent may be necessary if stress urinary incontinence persists.The patient currently has travel plans and wanted to wait until after october.The patient was referred to pain exposure in physical therapy (pept) for now.Additional information received on november 16, 2022: the patient was examined to establish care on (b)(6) 2021, at the clinic.The patient was reportedly diagnosed with urinary incontinence and gastroesophageal reflux disease without esophagitis.The patient has also just had a recent appointment with a cardiologist due to some chest pain and a burning feeling that came on after eating.The patient was directed to an internal medicine specialist to begin treatment since it was believed that the problem may be gastrointestinal in nature.The patient was then told to start taking omeprazole 40 mg per day.The patient specifically mentioned bowel incontinence as one of her several problems following the sling insertion procedure.The patient also intended to get surgery to correct the issue.Otherwise, the patient denies having any other complaints during her visit.No headaches, chest pain, or shortness of breath.Review of systems: constitutional: negative for chills and fever.Respiratory: negative for cough and shortness of breath.Cardiovascular: negative for chest pain and leg swelling.Gastrointestinal: positive for heartburn.Negative for abdominal pain, constipation, nausea and vomiting.Musculoskeletal: negative for joint pain and myalgias.Neurological: negative for dizziness and headaches.Psychiatric/behavioral: negative for depression and suicidal ideas.Additional information received on february 8, 2023: the patient has been experiencing urinary tract infections on and off since her last surgery, therefore she wishes to be examined in person on november 17, 2018.Moreover, the patient has reported having dysuria and urgent urination.Review of systems: respiratory: no shortness of breath.Cardiology: no chest pain.Constitutional: alert and oriented; well nourished.Urology: presence of voiding dysfunction and dysuria.Assessment: *recurrent herpes simplex virus (hsv) infection of buttock.*dysuria.Following mesh removal surgery in 2021, the patient's primary concerns on (b)(6) 2021, included urinary and bowel incontinence, vaginal spasms, pudendal neuralgia, and pelvic and buttock pain.The patient reports that symptoms have significantly impacted quality of life and that she has had to modify work hours due to symptoms.She exhibits poor pfm proprioception, pelvic floor muscle dysfunction, and replication of well-known pain with examination of the hip musculature.The physician has determined that in order to treat the issues and accomplish the objectives listed below, she needs skilled physical therapy in addition to a home exercise regimen.The possibility for rehabilitation is good overall.The patient has received information about the diagnosis, prognosis, and related pathology.Plan of care: amount, frequency and duration: frequency and duration: it is recommended that the client attend rehabilitative therapy three times per week for six weeks.Interventions will be geared on addressing the problems and achieving the previously stated goals during the course of treatment.The patient was seen for pelvic health physical therapy on (b)(6) 2021, to address primary concerns about pelvic pain and urinary and fecal incontinence.Due to illness, she returns to physical therapy for the first time since (b)(6) 2021.She reports decreased pain, but no improvement in urinary and fecal incontinence.She demonstrates a slight improvement in lumbar and gluteal musculature responsiveness, as well as enhanced pfm isolation and relaxation after contraction.According to her doctor, potential obstacles to success include inability to attend physical therapy and delay between sessions owing to illness.Observations: ambulating with single point cane.Coordination: pelvic floor muscle coordination deficits noted, and patient has poor isolation of pfm with gluteal recruitment; flicker contraction, able to lengthen.Additionally, the patient reported experiencing incontinence as a result of mesh removal and vulvar irritation on (b)(6) 2022.The patient's overall health history hasn't changed significantly since her last yearly exam.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a transobturator vaginal sling and cystoscopy procedure performed on (b)(6) 2018.For the treatment of stress urinary incontinence (sui).On (b)(6) 2018, the patient mentioned that she still had residual sui for 7 weeks post sling procedure, with symptoms that included dyspareunia, embarrassed, incontinence of urine, pelvic pain, and sexual dysfunction.Furthermore, the symptoms were exacerbated by coughing, sneezing, laughing, exercise, heavy lifting, and full bladder.In addition, pertinent medical history included recurrent urinary tract infections, kidney stones, rectocele, pelvic pain, stress urinary incontinence, and hematuria.Also, she had undergone bladder scan, and urine culture.Exam revealed good healing, the urethra was quite stable, but there was a fair amount of leakage with cough.The assessment was stress urinary incontinence.The patient was advised that she had tremendous leakage pre-op and the mesh sling has not solved it, so options included a bulking agent followed by an autologous pv sling.The patient was interested but her insurance would not cover coaptite.Urinalysis showed pyuria, and a culture was submitted.Results were not included in the medical records provided.On (b)(6) 2019, the patient presented for a second opinion for mixed incontinence, ongoing sui, frequency, bilateral groin pain, and dyspareunia.Her sui's onset was 10 years ago that got worse over time.Also, she had nocturia once to twice onset for about 9 months ago, and urgency only at night.Moreover, she only drank 1 serving of caffeine daily.The patient also experienced burning sensation from time to time, and only had a treatment once for urinary tract infection (uti).She stated that she's not sexually active due to pain which was not the case prior to her sling.Reportedly, there was no improvement on prior myrbetriq trial.She had 2 kidney stones with the last one on (b)(6) 2018, and had genital herpes which was treated with acyclovir, however, she had an outbreak a month ago.During the review of systems, the patient had mentioned that she had weight gain, dizziness, joint pain and back pain.Also, the patient had painful urination, frequent, urgent urination, incontinence, incomplete bladder emptying, nighttime urination, sexual dysfunction, vaginal pain, and vaginal burning.Exam revealed severe urethral hypermobility, perfuse cough stress test with no mesh exposed, and sling at mid-urethra and was tender.Reportedly, there was levator tenderness on the right, and pain at the inner aspect of muscles.Treatment options included sling excision and subsequent autologous pv sling, but the patient was advised she would need pelvic floor physical therapy (pfpt) and urodynamics study (uds) prior.On (b)(6) 2019, cystoscopy, uds, and complete urinalysis were performed.The patient was experiencing pelvic, perineal, vaginal and groin pain, stress incontinence, and mixed incontinence ever since she had the transobturator sling procedure.No abnormalities were noted on cystoscopy.Uds revealed abdominal leak point pressure (allp) of 58-128 cm h2o and pseudodyssenergia consistent with dysfunctional voiding.The assessment was pelvic and perineal pain, stress incontinence, and mixed incontinence.The physician had a discussion with the patient about proceeding with sling removal and to continue pelvic floor physical therapy (pfpt).The patient also understood that sui may still persist or worsen, and pain could not be resolved with the treatment.However, she still wanted to proceed with the sling removal and urethropexy.On (b)(6) 2019, the patient presented to pelvic health physical therapy (pt) with primary complaints and limitations with pelvic pain, vaginal pain, and groin pain.She also reported painful urination (urethral and bladder pain; 70% of the time), fecal incontinence 1x month with an urge, urinary incontinence (completely emptying of bladder with walking), nocturia 1-2x/night, and frequency (going every hour during the day).The patient was centrally sensitized with b multi-angle movement, severe reactivity upon light palpation through b adductors, severe pain upon palpation of all layers of pelvic floor muscles (pfm), observing moderate amounts of urine leakage with request to cough.The physical therapist recommended pre-habilitation pt to assist in desensitizing her myofascial and neurological system to set her up for successful surgery and recovery.On (b)(6) 2021, the patient was seen in a telemedicine appointment for fecal incontinence, sharp and excruciating bilateral pain slightly more on the right, and significant bladder burning.Since the surgery, the patient had not been able to have intercourse which was extremely painful.Moreover, she also developed numbness in both of her buttocks especially when sitting, and that numbness was around her rectum.The patient had fecal incontinence, but also had constipation.She has nocturia x2.Reportedly, she had significant hypersensitivity in the perineal area.In (b)(6) 2018, the patient started considering mesh removal but the physicians she saw said that the entire mesh cannot be removed so patient did not want to pursue this surgery as she felt very strongly that the entire mesh needs to be removed.The patient then wanted to have physical therapy but at that time she could not afford it.The patient felt that she was completely debilitated since implantation of mesh.The assessment included spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.The patient was advised that she has significant pudendal and obturator neuralgia caused by obtryx mesh.She had most likely developed significant spasm of the obturator internus muscle which put pressure on her pudendal and obturator nerves.She has symptoms of obturator neuralgia such as groin pain as well as symptoms of pudendal neuralgia such as rectal numbness with sitting.She also has allodynia which is consistent with neuropathic pain.Additionally, she has symptoms of pelvic floor muscle spasm such as nocturia and pain with intercourse.We have discussed treatment options and were going to proceed with removal of the entire obtryx mesh as well as bilateral pudendal nerve block and botulinum toxin a injection into pelvic floor muscles.If there is no improvement, she may be a candidate for bilateral pudendal neurolysis.On (b)(6) 2021, the patient presented for her pre-surgical counselling.She was scheduled to undergo removal of obtryx mesh - both vaginal part and bilateral groin, bilateral pudendal nerve block and botox injection to pelvic floor muscles.She was complaining of severe perineal/vulvar and vaginal pain.She had significant hypersensitivity in the clitoris and labia.Reportedly, the patient stated that she was not able to wear any underwear because for this burning hypersensitivity pain.She also stated that she was experiencing significant urinary incontinence.Furthermore, it was observed that there was bilateral lower back tenderness, bilateral lower abdominal tenderness, very significant bilateral spasm of the pelvic floor muscles especially obturator internus muscles bilaterally, and significant sensitivity to touch in the clitoris, bilateral labia, and the inner thighs.During assessment, it was noted that the patient had allodynia, spastic pelvic floor syndrome, obturator neuralgia, and pudendal neuralgia.During counseling, the physician had mentioned that the patent will most likely need repeat injections of botox to the pelvic floor muscles together with pudendal nerve blocks every three months for many years ahead.On (b)(6) 2021, the patient underwent vaginal mesh removal, groin mesh removal, pudendal nerve block, botox injection into pelvic floor, kelly plication, and osteotomy of pubic bone procedure for the pre-operative diagnoses of complication of implanted vaginal mesh, spastic pelvic floor syndrome, pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome type ii intraoperative findings included that the transobturator suburethral sling was densely attached to the medial aspect of the obturator foramen bilaterally, and there was a significant bilateral spasm of pelvic floor muscles.The mesh was identified and was very carefully dissected off the vaginal epithelium as well as the urethra and the bladder using sharp and blunt dissection.The dissection continued all the way behind the inferior ramus of the pubic bone on both sides.Approximately 4 cm incision was then made in the left genitofemoral crease and dissection was done until the fascia of the adductor muscles was identified.Fascia was then cut and after lengthy search the arm of the polypropylene mesh was identified.The mesh was found in the muscles of the groin in the area of expected placement of the mesh.It was then followed laterally until the cut end of it was identified.The mesh was then followed medially.The mesh was found to be very densely adherent to the dorsal side of the pubic bone medial to the obturator foramen.Using osteotome, a small piece of the pubic bone was removed allowing for complete removal of the transobturator mesh.A similar approach was taken on the right side for the right side of the mesh.The mesh was then removed completely from the right side and the vagina.This signifies that the entire polypropylene mesh was removed from the patient.The procedure was completed without complications.The patient was admitted for postoperative medical management postoperatively, the patient reported postoperative pain, with pain rated around 5/10, however, earlier it was rated up to 10/10, and she had some left leg tingling.The excised mesh and adherent tissue were submitted for pathology.The final pathologic diagnosis (gross examination) was foreign mesh material with no significant pathologic changes.Additional received on july 15, 2022: on (b)(6) 2022, the patient visited to discuss surgery, history of sling surgery and complained of incontinence.During the visit, the patient had bladder scan and urinalysis without micro.Although sling removal was performed on (b)(6) 2021, patient reported incontinence.Physical examination in vagina showed bilateral levator severely ttp and tight.Physician's note stated pudendal neuralgia, ongoing sui, nocturia, severe dyspareunia, not sexually active and no meds for oab.The patient did pelvic floor physical therapy four times a month; wears diapers and changes every 4 minutes; and voids every 2 hours.Lastly, discussion was made regarding uds appointment on (b)(6) 2022.Additional information received on september 23, 2022: on (b)(6) 2021, the patient reported of urinary and bowel incontinence (wearing diapers), vaginal spasms, pudendal neuralgia with groin pain following mesh removal surgery in 2021.The patient was going to have another surgery for incontinence sling which was still to be scheduled.The patient was walking with cane due to left leg giving out due to pain in the groin area.The patient reported that her muscles spasms started with mesh removal which was reportedly better with botox.It was reported that the patient needed an additional botox but she decided to put it off until the new year.The patient experienced "acid feeling" on skin between her legs with increased walking.She reportedly was not able to sit for any length of time.The patient reportedly to have not performed intercourse since 2018.On (b)(6) 2021, the patient has developed a severe case of being raw.Shee felt like acid was being poured on her.She was not sure what was causing the flare up.The patient was seen and examined if a catheter needs to be inserted.The patient was seen for pelvic health physical therapy to address concerns regarding urinary incontinence and pelvic pain.After patient needing to cancel several scheduled appointments due to increased symptoms, multiple attempts to contact the patient was made but have gone unanswered.The health care providers were unable to assess the patient's current understanding of the prognosis due to not completing plan of care and they were unable to assess the patient's current understanding of home exercises program due to not completing plan of care.The patient was choosing to discontinue therapy at this time.On (b)(6) 2022, the patient was seen and it was established that the patient had a history of persistent stress urinary incontinence after transobturator tape (tot) sling on (b)(6) 2018.The patient was seen in 2019 for a second opinion then lost to follow up.The patient since had extensive sling removal surgery on (b)(6) 2021 due to pudendal neuralgia.The patient is currently experiencing an ongoing stress urinary incontinence.The patient also reported nocturia.She wore diapers and changed every 45 minutes.The patient also reported to void every two hours.The patient was also experiencing sever dyspareunia and was not sexually active.Upon examination, the patient's bilateral levator was severely ttp and moderate urethral hypermobility was noted.Marshall-bonney test was positive.It was then concluded that the patient needed cystoscopy and urodynamic studies.On (b)(6) 2022, the patient still has an ongoing stress urinary incontinence.The patient underwent multiple pain exposure in physical therapy (pept) sessions which was not helpful after surgery.The patient's cystoscopy revealed negative results.Urodynamic study of the patient revealed multiple stress urinary incontinence low lpp and stress induced do.The risks and success rates of a pelvic sling were discussed with patient, and it was advised that a bulking agent may be necessary if stress urinary incontinence persists.The patient currently has travel plans and wanted to wait until after (b)(6).The patient was referred to pain exposure in physical therapy (pept) for now.Additional information received on november 16, 2022: the patient was examined to establish care on (b)(6) 2021, at the clinic.The patient was reportedly diagnosed with urinary incontinence and gastroesophageal reflux disease without esophagitis.The patient has also just had a recent appointment with a cardiologist due to some chest pain and a burning feeling that came on after eating.The patient was directed to an internal medicine specialist to begin treatment since it was believed that the problem may be gastrointestinal in nature.The patient was then told to start taking omeprazole 40 mg per day.The patient specifically mentioned bowel incontinence as one of her several problems following the sling insertion procedure.The patient also intended to get surgery to correct the issue.Otherwise, the patient denies having any other complaints during her visit.No headaches, chest pain, or shortness of breath.Review of systems: constitutional: negative for chills and fever.Respiratory: negative for cough and shortness of breath.Cardiovascular: negative for chest pain and leg swelling.Gastrointestinal: positive for heartburn.Negative for abdominal pain, constipation, nausea and vomiting.Musculoskeletal: negative for joint pain and myalgias.Neurological: negative for dizziness and headaches.Psychiatric/behavioral: negative for depression and suicidal ideas.

Manufacturer Narrative

Additional information: block b7 has been updated based on the additional information received on january 10, 2022.Block b3 date of event: the exact event onset date is unknown; however, it was reported that the patient had recurrent symptom on (b)(6) 2018.Block e1: this event was reported by the patient's legal representation.(b)(6).Block h6: imdrf patient codes e1310, e2328, e1309, e0402, e2401, e0123, e2330, e2112, e1405 and e2101 capture the reportable events of infection, urinary tract, obstruction, ureter/urethra (kidney stones), urinary retention (incomplete bladder emptying), hypersensitivity, injury, nos (not otherwise specified) for genital herpes, gerd (gastroesophageal reflux disease), subacute myoclonic spinal neuronitis, nerve damage (obturator neuralgia, pudendal neuralgia), pain (pelvic pain, groin pain, perineal pain, vaginal pain, joint pain, back pain, hip pain, bladder pain, allodynia), pain, intraoperative (acute), dyspareunia and adhesion respectively.Imdrf impact codes f1202, f1903, f19, f23, f22, and f2303 capture the reportable events of disability (debilitated), device explantation (removal of the vaginal part of sub-urethral transobturator sling, bilateral groin mesh removal), surgical intervention (osteotomy of left and pubic bone, kelly plication), unexpected medical intervention (pudendal nerve block, urodynamic study), unexpected diagnostic intervention (bladder scan, urine culture, urinalysis, cystoscopy), and medication required (botox injection to pelvic floor muscles) respectively.

• Brand Name: OBTRYX II SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11135093
• MDR Text Key: 226007076
• Report Number: 3005099803-2020-06674
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0021395394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/20/2022; 02/22/2022; 07/15/2022; 09/23/2022; 11/16/2022; 01/10/2023; 02/08/2023
• Supplement Dates FDA Received: 02/18/2022; 03/21/2022; 08/14/2022; 10/18/2022; 12/12/2022; 01/30/2023; 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White